Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Avainsanat
Abstrakti
Kuvaus
All patients will eat a balanced diet containing 1800 calories per day, but half of the patients in the study will take pre-made cinnamon extract pills three times a day, while the other half will take placebo pills (pills with no cinnamon extract) three times a day for 6 months. During this time, every patient will keep track of her period on a calendar.
Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the 6 months of medication. A total of 8 separate visits will be needed to finish the study. At the end of the study, the investigators will then compare the number of periods, blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.
Päivämäärät
| Viimeksi vahvistettu: | 05/31/2017 |
| Ensimmäinen lähetys: | 11/28/2011 |
| Arvioitu ilmoittautuminen lähetetty: | 11/29/2011 |
| Ensimmäinen lähetetty: | 11/30/2011 |
| Viimeisin päivitys lähetetty: | 09/04/2017 |
| Viimeisin päivitys lähetetty: | 10/02/2017 |
| Ensimmäisten tulosten toimittamispäivä: | 05/25/2016 |
| Ensimmäisten QC-tulosten toimittamispäivä: | 07/06/2017 |
| Ensimmäisten tulosten päivämäärä: | 08/01/2017 |
| Todellinen opintojen alkamispäivä: | 02/28/2011 |
| Arvioitu ensisijainen valmistumispäivä: | 04/30/2013 |
| Arvioitu tutkimuksen valmistumispäivä: | 03/31/2014 |
Ehto tai tauti
Interventio / hoito
Drug: Cinnamon Extract Arm
Dietary Supplement: Placebo Arm
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Active Comparator: Cinnamon Extract Arm PCOS patients receiving abstract of cinnamon | Drug: Cinnamon Extract Arm Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months. |
| Placebo Comparator: Placebo Arm PCOS patients receiving placebo capsules | Dietary Supplement: Placebo Arm Placebo capsules containing ground cereal. |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | Female |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | Inclusion Criteria: - Patients aged greater than 18 years of age - Ability to understand and willingness to comply with the study protocol - Written informed consent - Patients meeting the Rotterdam PCOS workshop criteria for polycystic ovary syndrome, defined by oligomenorrhea or amenorrhea and at least one of the following two signs: clinical or biochemical evidence of hyperandrogenism or ultrasound finding of polycystic appearing ovaries. Exclusion Criteria: - Current pregnancy or lactation - Liver disease or elevated liver enzymes - Established diagnosis of diabetes mellitus - Abnormal serum glucose levels either at fasting or after the 2-hr oral glucose tolerance test meeting criteria for the diagnosis of diabetes mellitus according to the American Diabetes Association. - Insulin sensitizing treatment within 3 months prior to or during the eight week study period. - Hormonal treatment involving estrogen or progesterone 3 months prior to or during the study period, with the exception of medroxyprogesterone acetate for withdrawal bleeding. - Systemic or inhaled corticosteroids. - Known hypersensitive reaction to cinnamon. - Patients with seizure disorders, known cardiovascular disease, or cerebrovascular disease. - Body mass index (BMI)range 20-50 (excluding all women with BMI under 20 or over 50). |
Tulokset
Ensisijaiset tulosmittaukset
1. Number of Menses During the Six Month Study Period. [Up to 6 months]
Toissijaiset tulosmittaukset
1. Change in Insulin Resistance [Baseline and 6 months]
2. Change in Glucose Response [Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion]
